药品名称DILACOR XR
申请号020092产品号001
活性成分DILTIAZEM HYDROCHLORIDE市场状态停止上市
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1992/05/29申请机构ALLERGAN SALES LLC
化学类型New formulation or new manufacturer审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
48391772006/12/09PDF格式
54221232012/06/06PDF格式
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
020092017APLetter2011/06/09下载
020092017APLabel2011/06/27下载
020092016APLetter2010/06/15下载
020092016APLabel2010/06/24下载
020092015APLetter2003/12/16下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
020092017AP2011/06/07Labeling Revision
020092016AP2010/06/08Labeling Revision
020092015AP2003/12/12Labeling Revision
020092014AP2001/08/07Manufacturing Change or Addition
020092011AP1998/10/28Manufacturing Change or Addition
020092010AP1996/03/20Control Supplement
020092009AP1995/10/31Manufacturing Change or Addition
020092008AP1995/02/02Manufacturing Change or Addition
020092007AP1995/02/09Package Change
020092006AP1995/02/09Manufacturing Change or Addition
020092005AP1995/03/02New or Modified Indication
020092004AP1993/12/06Labeling Revision
020092003AP1997/06/19Labeling Revision
020092002AP1992/10/15Labeling Revision
020092001AP1992/10/02Labeling Revision
020092000AP1992/05/29Approval